Job Details

Requisition Number 17-0012
Post Date 6/21/2017
Title Quality Engineer
City Buffalo
State NY
Description Multisorb Technologies welcomes qualified Quality Engineers to join our team! In this job you will
1. Perform work in a safe manner following all company/applicable safety rules and procedures. Identifies potential safety issues.
2. Commit to the Quality Policy and participation in, or support of related teams.
3. Understand and complies with all applicable regulatory requirements including the Company’s ISO/cGMP based quality system as documented in the Quality Manual, System Procedures, and Work Instructions.
4. Support and interface with all departments within the Company and with customers/auditors or suppliers on quality-related issues.
5. Conduct training on the Statistical Process Control (SPC) and related tools.

INSPECTION/TESTING/ANALYSIS
6. Work with Manufacturing Engineering and Research & Development departments to develop quality documents, inspection/test criteria and measurement systems for raw materials in-process and finished goods during product development.
7. Utilize statistical tools (DOE, ANOVA, etc.) to support establishment of quality requirements and/or verify product performance/compliance.
8. Design, recommends, purchases and institutes the use of measuring devices required to accomplish inspection and test functions.
9. Develop and evaluates sampling plans, procedures and statistical techniques.
10. Establish statistical confidence by identifying sample size and acceptable error; determines levels of confidence.
11. Evaluate inspection and test data involving production processes and finished product performance to ensure compliance to applicable specifications.
12. Determine quality improvement parameters by developing Statistical Process Control (SPC) plans for products, including performing capability studies and conducting Gage Repeatability & Reproducibility (GRR) analysis.
13. Develop, execute and maintain process qualifications/validations.
14. Identify and implement new measurement equipment and calibration procedures.
15. Develop inspection/sorting protocols when additional activity is necessary to ensure compliance to standards/specifications.
16. Conduct risk assessments to identify possible process/product failures and control mechanisms to mitigate risk.
17. Prepare technical reports by collecting, analyzing and summarizing data; makes recommendations based on this process.
18. Assist in the maintenance, use and training of the electronic SPC system. Recommends and implements additional components (hardware & software); develops reports based on SPC data and defect records.
19. Conduct root cause analysis to determine reasons for unstable processes that creates product variances and develops corrective actions in concert with Manufacturing Engineering and Operations Departments.
20. Acts as lead investigator (ombudsman) for related (PCAR) and customer complaints.

QUALTY STANDARDS
21. Perform internal and supplier audits to ensure compliance to applicable quality/regulatory systems.
22. Assist in the creation and maintenance of quality assurance policies and procedures.
23. Ensure procedures, systems and controls developed during the course of performing the Quality Engineering function are in conformance with applicable Good Manufacturing Practices (cGMP’s) and the corporate Quality Manual.

SUPPLIER CONTROL
24. Assist in Supplier Corrective Action (SCAR) including root cause analysis and development/management of action plans to minimize risk of non-conformances.
25. Assist Materials Department in maintaining the corporate Supplier Certification system to include evaluation of supplier surveys, performance of supplier audits and the development and institution of supplier history records.
26. Assist Materials Department in establishing standards and systems for measuring supplier performance and determines contractual quality clauses to be included when purchasing raw materials.

OTHER
27. Represents the Company to customers and/or suppliers on quality-related matters when required.
28. Assist the Process & Quality Engineering Leader on special projects as required.
29. Other duties as assigned.

Requirements Required: Bachelors Degree in Engineering or Science or Bachelors Degree in Quality Assurance, Industrial Engineering or Engineering Management
Required: 3-5 years in Quality Engineering
Preferred: 5+ years in Quality Engineering
Required: Experience with accessing/controlling Gage variation (GRR’s) as well as process variation through application of Statistical Process Control (SPC); Goal-oriented with ability to make action plans to meet goals; Adept at problem-solving and root cause analysis through use and utilization of scientific methods; Familiarity with quality planning activities; Good verbal and written communications; Familiarity with statistical analysis techniques, such as DOE and acceptance sampling plans; Ability to organize the flow of information and translate into meaningful reports that have good data presentation and are written in proper form; Knowledge of ISO quality systems; Familiarity with risk analysis, such as FMEA and Control Plans; Strong Minitab & MS Office Suite skills.
Preferred: Familiarity with packaging testing, vision systems, checkweighers, electronic data collection, SPC and ERP systems. Experience with 8D, 5-Why or similar root cause tools; Process/Software Validations; Regulatory knowledge such as CFR, USP & FCC requirements. Experience dealing with processing equipment and interaction with manufacturing personnel. Strong knowledge/experience with lean/six sigma.
Statistical Process Control (SPC)
High Performance Work Teams, Problem Solving Basics; Certified Quality Engineer (CQE), Certified Green Belt, Pharma or Medical Device related Validation training, HACCP training, Lean/Six Sigma.
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